RecruitingNCT06923150

A Randomised Clinical Investigation to Assess Efficacy of Low Volume Transanal Irrigation by Qufora® IrriSedo MiniGo Versus Conservative Treatment for Low Anterior Resection Syndrome Patients

Sponsor

Qufora A/S

Enrollment

78 participants

Start Date

Jun 18, 2024

Study Type

OBSERVATIONAL

Conditions

Rectal Cancer LARS - Low Anterior Resection Syndrome Gastroenterology

Summary

The purpose of this post-market clinical follow up study is to assess the efficacy on clinical symptoms of LARS of low volume Transanal Irrigation by MiniGo in conjunction with conservative treatment versus conservative treatment at 3 months.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

Adult aged from 18 years
Patients electively treated for rectal cancer with a low anterior resection
Between 3 and 18 months after the conservative colorectal surgery or 3 and 18 months after the stoma reversal if applicable
LARS score \>= 25 (minor or major LARS) (Emmertsen and Laurberg 2012) AND LARS definition as consensus with at least one symptom that results in at least one consequence (Keane et al. 2020)
Adult for whom previous conservative treatments were started for at least a month
Mental and physical capability of the patient to handle the MiniGo by himself.
Check of the anastomosis (no signs of leakage or clinical relevant stenosis) and absence of local recurrence by Rectal digital examination of the anastomosis, any other exam used in the current practice
Patient affiliated to the health social security system

Exclusion Criteria16

Contra-indication to use TAI
Former use of TAI (post colo-rectal surgery)
Clinically relevant stenosis
Current metastatic disease or local recurrence
Ongoing chemotherapy
Postoperative radiotherapy for rectal cancer
History of diarrhoeal disease
Inflammatory bowel disease
Dementia
Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant disease assessed to be a contributory cause to LARS symptoms.
Patient with cancer recurrence
Patient with a life expectancy \< 1 year
Participating to another clinical trial for the treatment of LARS symptom
Ongoing pelvic floor rehabilitation/biofeedback
Pregnancy or intention to become pregnant during the trial period
Inability and unwillingness to give informed consent